CAM in Veterans With Gulf War Illnesses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Veterans RAND 36-item Health Survey - Mental Component Summary Scale
研究概览
简要总结
The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE) and iRest Yoga Nidra (mindfulness meditation)/auricular (ear) acupuncture for Veterans with Gulf War Veterans' Illnesses (GWVI).
详细描述
Gulf War Veterans have reported irritable bowel syndrome, chronic fatigue, musculoskeletal pain, sleep difficulties, and neurocognitive dysfunction (for example, concentration, memory, and attention problems). The most effective treatment approach for what appears to a broad spectrum problem found in GWVI may require complementary alternative medicine (CAM) approaches to enhance positive outcomes. Mindfulness meditation and acupuncture are each broad spectrum CAM treatments designed to target multiple biological systems simultaneously, and thus may be well suited for GWVI. Gulf War Health Education group will promote wellness and prevention by utilizing a proactive patient care model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
RBANS assessment was blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •U.S. Veteran
- •Deployed to the Gulf War between 1990-1991
- •Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)
排除标准
- •Addiction to drugs or alcohol
- •Experiences hallucinations or delusions
- •Currently manic
- •Currently suicidal
- •Hearing difficulties that would interfere with group participation
- •Current involvement in a meditation or acupuncture group
结局指标
主要结局
Veterans RAND 36-item Health Survey - Mental Component Summary Scale
时间窗: 8 weeks
The MCS is comprised of questions about role-emotional, vitality/mental health and social functioning. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale
时间窗: 8 weeks
The PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a
时间窗: 8 weeks
An 8-item NIH instrument consisting of eight items that asks about the experience and impact of fatigue. Higher scores represent greater symptom severity. Range from 0 - 32.
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a
时间窗: 8 weeks
An eight-item self-reported pain instrument designed at the National Institutes of Health (NIH) to measure the extent to which pain interferes with involvement in cognitive, emotional, physical, recreational, and social activities. Higher scores represent greater symptom severity. Range from 0 - 32.
次要结局
- Short-form McGill Pain Questionnaire (SF-MPQ-2)(8 weeks)
- Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF)(8 weeks)
- Quality of Life in Neurological Disorders (Neuro-QoL)(8 weeks)
- Patient Health Questionnaire-Depression Module (PHQ-9)(8 weeks)
- Perceived Stress Scale (PSS)(8 weeks)
- Posttraumatic Symptom Checklist - Civilian Version (PCL-C)(8 weeks)
- The Brief Symptom Inventory (BSI)(8 weeks)